Difference between revisions of "Dinutuximab (Unituxin)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*3/10/2015: Initial FDA approval in combination with [[Sargramostim (Leukine)|granulocyte-macrophage colony-stimulating factor (GM-CSF)]], [[Aldesleukin (Proleukin)|interleukin-2 (IL-2)]], and [[Isotretinoin (Accutane)|13-cis-retinoic acid (RA)]], for the treatment of pediatric patients with high-risk [[Neuroblastoma|neuroblastoma]] who achieve at least a partial response to prior first-line multiagent, multimodality therapy. ''(Based on COG ANBL0032)'' | *3/10/2015: Initial FDA approval in combination with [[Sargramostim (Leukine)|granulocyte-macrophage colony-stimulating factor (GM-CSF)]], [[Aldesleukin (Proleukin)|interleukin-2 (IL-2)]], and [[Isotretinoin (Accutane)|13-cis-retinoic acid (RA)]], for the treatment of pediatric patients with high-risk [[Neuroblastoma|neuroblastoma]] who achieve at least a partial response to prior first-line multiagent, multimodality therapy. ''(Based on COG ANBL0032)'' | ||
| − | + | ==History of changes in EMA indication== | |
| + | *8/14/2015: Initial authorization for the treatment of high risk [[neuroblastoma]]. | ||
| + | *3/20/2017: Authorization withdrawn at the request of the manufacturer, for supply chain reasons | ||
== Patient Drug Information== | == Patient Drug Information== | ||
*[https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125516s000lbl.pdf Dinutuximab (Unituxin) Package Insert]<ref>[https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125516s000lbl.pdf Dinutuximab (Unituxin) Package Insert]</ref> | *[https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125516s000lbl.pdf Dinutuximab (Unituxin) Package Insert]<ref>[https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125516s000lbl.pdf Dinutuximab (Unituxin) Package Insert]</ref> | ||
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[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
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[[Category:Anti-GD2 antibodies]] | [[Category:Anti-GD2 antibodies]] | ||
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[[Category:Neuroblastoma medications]] | [[Category:Neuroblastoma medications]] | ||
| + | [[Category:EMA approved in 2015]] | ||
[[Category:FDA approved in 2015]] | [[Category:FDA approved in 2015]] | ||
| + | [[Category:EMA withdrawn in 2017]] | ||
Revision as of 13:51, 3 January 2023
Mechanism of action
From the NCI drug dictionary: A chimeric mouse/human monoclonal antibody with potential antineoplastic activity. Dinutuximab binds to the ganglioside GD2 and induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity against GD2-expressing tumor cells.
Route: IV
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.
Diseases for which it is used
History of changes in FDA indication
- 3/10/2015: Initial FDA approval in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. (Based on COG ANBL0032)
History of changes in EMA indication
- 8/14/2015: Initial authorization for the treatment of high risk neuroblastoma.
- 3/20/2017: Authorization withdrawn at the request of the manufacturer, for supply chain reasons
Patient Drug Information
Also known as
- Code names: Ch14.18, MOAB Ch14.18, monoclonal antibody Ch14.18
- Brand name: Unituxin